MAUDE Adverse Event Report: B BRAUN MEDICAL, INC PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY WITH PERIFIX 18 GA X 3-1/2 IN TUOHY

Lot Number 61364311

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Pt s/p repeat c-section on (b)(6) 2014 with use of epidural anesthesia.Upon discontinuation of the epidural catheter on (b)(6) 2014, it was noted that the blue tip was not present on the end of the epidural catheter.It appears to have stretched when lined up next to a non-used catheter of the same type.Follow up ct did not reveal presence of catheter.Neurosurgeon did not feel intervention was required.

• Brand Name: PERIFIX CONTINUOUS EPIDURAL ANESTHESIA TRAY WITH PERIFIX 18 GA X 3-1/2 IN TUOHY
• Type of Device: CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): B BRAUN MEDICAL, INC
• MDR Report Key: 3966418
• MDR Text Key: 17991277
• Report Number: MW5037477
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/01/2015
• Device Lot Number: 61364311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 36 YR